Beckman Coulter, Inc.

Beckman Coulter, Inc.: 12 recalls listed since January 2026 across FDA.

By year

Beckman Coulter Rotor SW40 and SW41 may break into two or more pieces.

Moderate riskFDAOct 21, 2026Device defect

The DxU 840m Iris, DxU 850m Iris, IQ200 Sprint, IQ200 Select, and IQ200 Elite may leak lamina fluid, posing slip, chemical.

Moderate riskFDAOct 15, 2026Device defect

DxC 500 AU and DxC 500i analyzers have a software issue that can revert test units to default without warning, causing falsely elevated results.

Moderate riskFDAOct 2, 2026Software defect

Beckman Coulter DxC 500i Clinical Analyzer Modules have a software defect that can cause erroneous patient test results.

Moderate riskFDAAug 17, 2026Software defect

MicroScan LabPro V5.03 Panel Update 11 has incorrect algorithms that may affect antimicrobial susceptibility test results.

Moderate riskFDAAug 5, 2026Software defect

The Access Total T4 Calibrator shows a negative bias on DxI 600/800 instruments, with slopes outside specifications.

Moderate riskFDAApr 22, 2026Device defect

MicroScan Neg Multidrug Resistant MIC 1 has a manufacturing issue with in vitro multidrug resistant test.

Moderate riskFDAApr 8, 2026Manufacturing problem

MicroScan Neg MIC 3J is missing a drug in well 4/4 but contains double the amount of antibiotics.

Moderate riskFDAApr 3, 2026Manufacturing problem

MicroScan panels may be contaminated in some wells.

Moderate riskFDAMar 20, 2026Contamination

The CellMek SPS Sample Preparation System has a software error that can cause sample loss and incorrect diagnosis.

Moderate riskFDAFeb 2, 2026Software defect

Coulter DxH Diluent and ECO Diluent can cause elevated platelet background counts with use.

Moderate riskFDAJan 30, 2026Device defect

Beckman Coulter UniCel Dxl 600 and UniCel Dxl 800 analyzers may not restart after a standard shutdown, causing delayed results.

Moderate riskFDAJan 6, 2026Device defect